Following Maharashtra Food and Drug Administration (FDA) action against DRL for supplying spurious products to doctors' clinics in violation of Section 18 (a) (1) of Drugs and Cosmetics Act, the appellate authority, the State FDA minister, has given a hearing recently to deliver judgment for further action.

The State regulator had earlier taken administrative action against the company by issuing an order to suspend drug licences for violation of Rules 65 (5) (1) and 65 (5) (3) (ii) of the Drugs and Cosmetics Act, 1940 for serious lapses in terms of documentation and storage at company’s warehouse situated at Bhiwandi near Thane.

The FDA assistant commissioner and licensing authority G K Vakharia in his order released on November 19, 2014 had suspended drug licences for the period January 12 to February 10, 2015 under Rules 66 (1) and 67 (H) of the Act. It was observed that the samples of hand sanitiser were found to be not of standard quality.

Bombay High Court had earlier granted an interim stay when the drug maker had approached the court on the state government's suspension order on the company's C&F agent after the state regulator found violations with regard to some samples found in the warehouse of the company.

High Court had granted an interim stay on the matter on January 8 for two weeks and Dr Reddy's approached the State FDA minister on January 12 based on the court directive.

"In our opinion there has been no violation of any statute or regulation by the company and it has been in compliance. The order relates only to the wholesale licence of the clearing and forwarding agent. The product being investigated is not a drug and is neither manufactured nor marketed by us," a spokesperson of Dr Reddy's had clarified.

The state FDA said the competent authority's full signature was missing and the short signature found during inspection of the Bhiwandi premises was not identical with the original signature of the said authority. FDA had also found fault with maintenance of stock transfer notes, saying they were not kept in the chronological manner.

In its appeal to the state medical education department Dr Reddy’s Laboratories stated, “If the licence is suspended then irreparable loss will be caused because the company will have to stock its drugs at other warehouses. Its various products would not be made available to the stockists thereby resulting in shortage of drugs to its consumers mainly patients suffering from various sickness and diseases”.

The company officials further explained that the products being distributed through medical representatives are promotional items and not for sale. The documents verified were the stock transfer notes that are accompanied along with the products when products are being transferred from one location to another and they are not classified as sale but mere transfer between the locations for facilitating business operations.